After a whole bunch of criticism got heaped on Pathway Genomics (the maker of at-home genetic testing kits) and Walgreens, the drugstore chain has decided not to begin offering the test kits at the originally planned 6,000 of 7,500 locations Friday.
It seems that FDA concerns and a letter sent by the agency to Pathway Genomics requesting further information on the product caused Walgreens to back away from distributing the kit. Walgreens said:
“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” Jim Cohn, a Walgreens spokesman, said late Wednesday.
This evening, the FDA released a letter dated May 10th requesting information validating the products’ claims. FDA Deputy Director for Patient Safety and Product Quality James Woods said that the regulatory agency hasn’t been able to identify any “clearance or approval number” for the controversial product. In the letter, Woods says:
“If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us for the basis for the determination.”
Pathway responded, asserting that the kit complies with regulations:
“Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines,” Pathway said in a statement issued Wednesday in response to the FDA’s inquiry. “Our laboratory is federally CLIA-certified and state-licensed. We have provided the same personal genetic report to customers for the past year, and are continuing discussions with the FDA about the regulation of personal genomic information.”
It is unclear whether Walgreens will decide to carry the kits if FDA approval is obtained.
[Chicago Breaking Business via Consumerist ]
